Claims for Patent: 10,190,170

Summary for Patent: 10,190,170

Title:	Maker for diagnosing HER2 inhibitor resistant cancer, diagnostic kit comprising same, and method for diagnosing HER2 inhibitor resistant cancer
Abstract:	The present invention relates to a composition for detecting a marker for diagnosing an HER2 inhibitor-resistant cancer, a diagnostic kit including same, and a method for detecting the marker. More particularly, the present invention relates to a composition for detecting a maker for diagnosing an HER2 inhibitor-resistant cancer, a diagnostic kit including same, and a method for detecting the marker, wherein the present invention allows presence and absence of resistance to an HER2 inhibitor, which is typically prescribed to an HER2-positive cancer patient, in an HER2-positive cancer patient to be determined in an easier manner with remarkably high reliability.
Inventor(s):	Chang; Hae Ryung (Yeongdeungpo-gu, KR), Gim; Youme (Gwanak-gu, KR), Jung; Hae Rim (Goyang-si, KR), Nam; Seung Yoon (Seongbuk-gu, KR), Ro; Jung sil (Yongsan-gu, KR), Kim; Yon Hui (Seocho-gu, KR)
Assignee:	NATIONAL CANCER CENTER (Goyang-si, KR)
Application Number:	14/726,390
Patent Claims:	1. A method for providing information about prognosis of an HER2-positive breast cancer patient about administration of trastuzumab and treating the HER2-positive breast cancer patient, the method comprising: (a) obtaining a sample from the HER2-positive breast cancer patient who are taking the trastuzumab: (b) treating the sample with the trastuzumab for 24 to 48 hours; (c) measuring an expression level of mRNA of ENAH gene and an expression level of HER2 protein from the sample of (b); (d) diagnosing the HER2-positive breast cancer patient having trastuzumab resistance when the measured expression level of mRNA of ENAH gene is higher than an expression level of mRNA of the corresponding gene in the sample before treating with the trastuzumab, and the measured expression level of HER2 protein is lower than an expression level of the corresponding protein in the sample before treating with the trastuzumab; and (e) administering a second-line drug to the patient diagnosed as having trastuzumab resistance. 2. A method for diagnosing a presence or an absence of trastuzumab resistance in an HER2-positive breast cancer patient and treating the HER2-positive breast cancer patient, the method comprising: (a) obtaining a sample from the HER2-positive breast cancer patient; (b) treating the sample with the trastuzumab for 24 to 48 hours; (c) measuring an expression level of mRNA of ENAH gene and an expression level of HER2 protein from the sample of (b); (d) diagnosing the HER2-positive breast cancer patient having trastuzumab resistance when the measured expression level of mRNA of ENAH gene is higher than an expression level of mRNA of the corresponding gene in the sample before treating with the trastuzumab, and the measured expression level of HER2 protein is lower than an expression level of the corresponding protein in the sample before treating with the trastuzumab; and (e) administering a second-line drug to the patient diagnosed as having trastuzumab resistance.

Details for Patent 10,190,170

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Genentech, Inc.	HERCEPTIN	trastuzumab	For Injection	103792	09/25/1998		2034-06-20
Genentech, Inc.	HERCEPTIN	trastuzumab	For Injection	103792	02/10/2017		2034-06-20
Genentech, Inc.	HERCEPTIN HYLECTA	trastuzumab and hyaluronidase-oysk	Injection	761106	02/28/2019		2034-06-20